Tushti Shah

Manufacturing, Science and Technology Group Scientist- i @SUN PHARMA

Performed all activities towards technical transfer, hold time studies, design of experiments for QBD, Scale up, process optimization, continuous process improvement, alternate source qualification, exhibit batches, process validation batches, etc. • Developed a strong documentation package, involving from conceptual study to various phases of product development like process study, characterization, process qualification and cleaning validation. • Prepared and reviewed controlled documents to ensure accuracy of data and content which include: Change control, Master Batch Records, Master Packaging Records, validation summary reports, Investigation Reports, Process optimization Reports, Validation Protocols/report and Standard Operating Procedures (SOPs) etc. Maintained electronic version of control documents. • Investigated any deviations or failures related to product quality, engineering trials, validation protocols and reports, and other compliance-related tasks (FDA, DEA, OSHA, and others). • Worked with cross-functional team that address specific problems, facilitate discussion and research, enabling procedures to become more efficient.